Clearance Summary
SELF-CONTAINED MOBILE OPHTHAL. OPER. . received FDA 510(k) clearance under submission number K822427, sponsored by Surgi-Quip Inc.U. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1982-09-14.
- Submission: K822427
- Applicant / Sponsor: Surgi-Quip Inc.U
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1982-09-14
Classification & Regulation
This clearance is catalogued under FDA product code FSE and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.